Functional Abdominal PainLGGDARNCT00876291
Efficacy of Lactobacillus GG (LGG) in Children With Abdominal Pain
A study testing Lactobacillus GG (probiotic ) in people with Functional Abdominal Pain, run by University of Bari at 1 site in Italy.
Trial summary
Probiotics play an important role in preventing overgrowth of potentially pathogenic bacteria and maintaining the integrity of the gut mucosal barrier. The beneficial effects of probiotics have been previously studied in adult patients with IBS. Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Functional Abdominal Pain
- What is being tested?
- Lactobacillus GG (probiotic )
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2004to Aug 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients were considered for study inclusion, if they were 4 - 12 years of age and had if they had a pain history of at least 12 weeks (which need not be consecutive) in the preceding 12 months suggestive for IBS or FAP with no structural or metabolic abnormalities to explain the symptoms and according to the Rome II diagnostic criteria valid at the time of the design of the study.
- IBS was diagnosed in presence of an abdominal discomfort or pain with at least two of three features:
- relieved with defecation
- onset associated with a change in stool frequency
- onset associated with a change in the form (appearance) of the stool.
- FAP was diagnosed in presence of symptoms of
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- Continuous (nearly continuous) abdominal pain
- No or only occasional relation of pain with physiological events (e.g. eating, menses)
- Some loss of daily functioning
- The pain is not feigned (e.g. malingering)
- The patient has insufficient criteria for other functional gastrointestinal disorders that would explain the abdominal pain.
Who cannot join
- Known concomitant psychiatric, neurological, metabolic, hepatic, renal, infectious, haematological, cardiovascular and pulmonary disease
- Treatment with antibiotics/probiotics in the last 2 months
- A pain history suggestive for functional dyspepsia or aerophagia or abdominal migrain
- Growth failure
- Gastroparesis
- Gastrointestinal obstructions/stricture
- Any disease that may affect bowel motility such as diabetes, connective disease or poorly controlled hypo/hyperthyrodism
- Previous abdominal surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Lactobacillus gg in Functional Abdominal Pain in Children: a Double-blind Randomized Control Trial
Probiotics play an important role in preventing overgrowth of potentially pathogenic bacteria and maintaining the integrity of the gut mucosal barrier. The beneficial effects of probiotics have been previously studied in adult patients with IBS. Even though most of the studies demonstrate efficacy, other studies do not support these observations. Few studies addresses the efficacy of probiotics in children with IBS. The goal of the present study was to determine whether oral administration of the probiotic Lactobacillus GG under randomized, double-blind, placebo-controlled conditions would improve symptoms of children with abdominal pain.
- Conditions
- Functional Abdominal Pain
- Being tested
- Lactobacillus GG (probiotic ), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus GG (probiotic )Dietary supplement
LGG capsules: each cp containing 3 × 109 colony forming units, CFU
PlaceboDietary supplement
placebo which consisted of capsules identical in taste and appearance to the active study product except for the absence of freeze-dried LGG (and cryoprotectants)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | placebo which consisted of capsules identical in taste and appearance to the active study product except for the absence of freeze-dried LGG (and cryoprotectants) Receives: Dietary Supplement: Placebo |
| Probiotic | Active comparator | LGG capsules: each cp containing 3 × 109 colony forming units, CFU Receives: Dietary Supplement: Lactobacillus GG (probiotic ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure was defined as reduction of pain (both number of episodes and intensity) at the end of the intervention.
Measured: 12 weeks and 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2009 (estimated)
- Study startDec 2004
- Primary completionDec 2007
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional Abdominal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Collaborators
- Clinica PEdiatrica Ospedale San Paolo Bari Italy
- Investigators
- Ruggiero Francavilla, MD PhD, Principal investigator, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876291
- Sponsor's protocol ID
- UB2712
- Acronym
- LGGDAR
- Status last verified
- Apr 2009
- First submitted
- 2 Apr 2009
- Last updated
- 1 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Francavilla R, Miniello V, Magista AM, De Canio A, Bucci N, Gagliardi F, Lionetti E, Castellaneta S, Polimeno L, Peccarisi L, Indrio F, Cavallo L. A randomized controlled trial of Lactobacillus GG in children with functional abdominal pain. Pediatrics. 2010 Dec;126(6):e1445-52. doi: 10.1542/peds.2010-0467. Epub 2010 Nov 15.
PubMed 21078735
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Lactobacillus gg in Functional Abdominal Pain in Children: a Double-blind Randomized Control Trial
- ClinicalTrials.gov ID
- NCT00876291
- Acronym / sponsor ID
- LGGDAR / UB2712
- Conditions
- Functional Abdominal Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of BariUniversity, hospital or other
- Collaborators
- Clinica PEdiatrica Ospedale San Paolo Bari Italy
- Study start
- Dec 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 6 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Probiotics play an important role in preventing overgrowth of potentially pathogenic bacteria and maintaining the integrity of the gut mucosal barrier. The beneficial effects of probiotics have been previously studied in adult patients with IBS. Even though most of the studies demonstrate efficacy, other studies do not support these observations. Few studies addresses the efficacy of probiotics in children with IBS. The goal of the present study was to determine whether oral administration of the probiotic Lactobacillus GG under randomized, double-blind, placebo-controlled conditions would improve symptoms of children with abdominal pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placeboplacebo which consisted of capsules identical in taste and appearance to the active study product except for the absence of freeze-dried LGG (and cryoprotectants) |
| Probiotic | Active comparator | Dietary Supplement: Lactobacillus GG (probiotic )LGG capsules: each cp containing 3 × 109 colony forming units, CFU |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Patients were considered for study inclusion, if they were 4 - 12 years of age and had if they had a pain history of at least 12 weeks (which need not be consecutive) in the preceding 12 months suggestive for IBS or FAP with no structural or metabolic abnormalities to explain the symptoms and according to the Rome II diagnostic criteria valid at the time of the design of the study.
- IBS was diagnosed in presence of an abdominal discomfort or pain with at least two of three features:
- FAP was diagnosed in presence of symptoms of
- Continuous (nearly continuous) abdominal pain
- No or only occasional relation of pain with physiological events (e.g. eating, menses)
Key exclusion criteria (8 listed)
- Known concomitant psychiatric, neurological, metabolic, hepatic, renal, infectious, haematological, cardiovascular and pulmonary disease
- Treatment with antibiotics/probiotics in the last 2 months
- A pain history suggestive for functional dyspepsia or aerophagia or abdominal migrain
- Growth failure
- Gastroparesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus GG (probiotic )LGG capsules: each cp containing 3 × 109 colony forming units, CFU | Dietary supplement | Probiotic |
| Placeboplacebo which consisted of capsules identical in taste and appearance to the active study product except for the absence of freeze-dried LGG (and cryoprotectants) | Dietary supplement | Placebo |
Primary outcome
The primary outcome measure was defined as reduction of pain (both number of episodes and intensity) at the end of the intervention.
Time frame: 12 weeks and 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2011.
- Derived from this study: PubMed 21078735Francavilla R, Miniello V, Magista AM, De Canio A, Bucci N, Gagliardi F, Lionetti E, Castellaneta S, Polimeno L, Peccarisi L, Indrio F, Cavallo L. A randomized controlled trial of Lactobacillus GG in children with functional abdominal pain. Pediatrics. 2010 Dec;126(6):e1445-52. doi: 10.1542/peds.2010-0467. Epub 2010 Nov 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruggiero Francavilla, MD PhD principal investigator
University of Bari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus GG (probiotic ) in people with Functional Abdominal Pain, run by University of Bari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure was defined as reduction of pain (both number of episodes and intensity) at the end of the intervention. (time frame: 12 weeks and 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00876291, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2011.